Senior Manager of Quality and Regulatory Affairs (Metro-NY)
Premier Brands of America Inc - Mount Vernon, NY

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Director of Quality Assurance & Regulatory Affairs:

The Director of Quality Assurance and Regulatory Affairs oversees both the Quality and Regulatory departments at Premier Brands of America to ensure compliance with all company, government and customer regulations and standards.

Premier is a rapidly growing, privately held manufacturer and marketer of high-quality OTC and non-OTC medical devices and other health and beauty aid products. Premier’s product line includes over 150 different items that provide comfort and care in the First Aid, Foot Care, Medicated Spray, and Beauty categories. Premier’s products can be found in over 50,000 stores in the United States and abroad under its own brand and over 30 unique store brands.

Premier strives to stay ahead of the competition by maintaining a fast-paced, intimate work environment that employs only the strongest of players. Come work for a company in which you will make a visible impact on all aspects of the operation. One in which your thoughts and efforts will be valued, respected and followed. One with a culture that truly prides itself on properly and efficiently getting things done, and encourages having fun while doing it.

Job Description:

  • Manage the daily operations of the Quality and Regulatory departments.
  • Maintain understanding and ensure company-wide adherence to all FDA and appropriate international regulatory requirements pertaining to the manufacture and packaging of OTC products.
  • Establish and maintain a Quality System to ensure that the company strictly follows government regulations, as well as customer and company standards relevant to good manufacturing practices, product quality and safety, company goals, etc.
  • Ensure all submissions to the FDA and other Regulatory bodies are performed in a timely manner.
  • Extensive interaction with government and customer regulatory agencies.
  • Work cooperatively with Marketing and other departments in the development of new products.
  • Review and approve the labeling and packaging of Premier’s products.
  • Develop, maintain, and/or enforce select SOPs, MSDS, etc.
  • Field and document customer complains concerning products and ensure that systemic issues are addressed.
  • The position reports directly to the company COO.

Requirements:

  • Strong working knowledge of U.S. OTC and medical device regulatory requirements.
  • A Bachelor’s degree in either a technical or science field is required. Advanced degree is a plus.
  • Must have 3-5 years of Quality Engineering experience.
  • 3 years of management experience is required.
  • Experience with stability management and/or quality control testing. Validation experience is a huge plus.
  • Ability to work cross-functionally with other departments, primarily manufacturing operations and the product development side of Marketing.
  • It is imperative that the individual is detail-oriented and highly organized.
  • Must be a positive, energetic team player with the ability to manage, multitask, and respond to the urgent needs of the team to meet deadlines.

Compensation:

  • Base salary
  • Benefits: Health, Dental, 401K, Paid Vacation
  • Opportunity for growth

Location:

  • The Director of Quality Assurance and Regulatory Affairs will be based at the Company’s operations headquarters in Mount Vernon, New York (Westchester County).
  • Easily commutable from NYC, Northern NJ, and Connecticut via auto, subway, train, and bus.

Contact:

  • Please email resume
  • No calls, please

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